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Regulatory Affairs Executive (ID: 687615)
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Regulatory Affairs Executive (ID: 687615)
Job summary
A private pharmaceutical company in Singapore is seeking a Regulatory Affairs Executive. The successful candidate will assist in regulatory goals, manage product registrations for healthcare products, and liaise with cross-functional teams to ensure compliance. Candidates should have a degree in Pharmacy or related fields and at least 2 years experience in regulatory affairs. The role offers clear career pathways within a reputable organization with growth opportunities.
Benefits
Qualifications
- At least 2 years of experience in regulatory affairs, preferably in the pharmaceutical or consumer healthcare industry.
- Knowledge of regulatory procedures (e.g., US FDA / EMA / ICH / PIC/S framework) is an added advantage.
- Familiarity with risk management tools.
Responsibilities
- Assist to work towards achieving regulatory goals.
- Support product registration, variations and renewal submissions for consumer health products.
- Liaise with cross-functional teams to ensure regulatory compliance.
- Maintain registration status of marketed products.
- Stay informed of evolving regulatory requirements.
- Provide technical support on change management and new product development.
- Maintain a systematic archive of marketing materials.
- Handle ad-hoc projects assigned by management.
Skills
Education
Our esteemed client in the private pharmaceutical company is seeking to hire a Regulatory Affairs Executive to join their growing team!
- Work Location Accessible by Public Transport
- Reputable Global Organization with Strong Market Presence
- Clear Career Pathway & Progression Opportunities
- Assist to work along with internal and external units towards achieving common strategic regulatory goals.
- Provide support in regulatory affairs (RA) for product registration, variations and renewal submissions (consumer health care products e.g. OTC/generics, health supplements, cosmetics and medical device). Maintain and track the registration status of all marketed products in compliance with relevant regulations.
- Liaise with cross‑functional teams including Marketing, Quality and R&D to ensure regulatory compliance across product lifecycle activities such as artwork and labeling, claims substantiation, health authority queries, new product development, and change controls.
- Stay informed of evolving regulatory requirements; assess and communicate their impact and support the supervisor in driving necessary actions to maintain compliance.
- Provide technical support and work closely with the relevant stakeholders (internal, external) on change management of raw materials/packaging materials as well as new product development (NPD) process.
- Work with the business units on NPD requirement, review and evaluate together with the technical team from manufacturing operations on the product concept/formulation/data analysis.
- Maintain a systematic archive of marketing materials (advertisements, social media posts, POSM, packaging artworks, digital and print campaigns) for each market and product.
- Ad‑hoc projects and tasks assigned by the management.
- Degree in Pharmacy, Life Sciences, Applied Chemistry or equivalent
- At least 2 years of experience in regulatory affairs - handling product registration preferably in the pharmaceutical line, consumer healthcare products or related industry.
- Knowledge of Asia Pacific regulatory procedures & guidelines (e.g., US FDA / EMA / ICH / PIC/S framework) is an added advantage.
- Familiar with risk management tools/principles.
- Some exposure in product innovation/NPD and/or legal agreement matter is an advantage
- Good documentation and project management skills
Interested candidates who wish to apply for the advertised position, please click on “Apply”. We regret that only shortlisted candidates will be notified.
EA License No.: 01C4394 (PERSOL Singapore PTE LTD)
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